Clinical sensitivity for HBV in HK blood donors was equivalent, as was the analytical sensitivity for HIV-1 and HBV; however, the Ultrio assay had a higher analytical sensitivity for HCV. Despite a shorter downtime and mean time of repair for the cobas s 201, the TIGRIS demonstrated better overall operational performance.

This study demonstrated a substantially higher prevalence of OBI compared to acute serologic window period HBV infections in Australian blood donors. Follow-up testing of OBI cases indicates that HBV DNA is often only intermittently detectable in OBI, highlighting the importance of including anti-HBc to optimize the HBV testing algorithm.

The results presented in this report demonstrate that the sequential use of screening immunoassays before immunoblot testing can significantly reduce both the number of immunoblot tests and proportion of indeterminate results, without impacting sensitivity, thereby improving algorithm efficiency and simplifying donor management.

The comparison of the performance of PDT with SDT sites identified only minor differences that did not adversely impact on the timely release of blood products. Although both ID and MP strategies showed excellent specificity, irrespective of site configuration, the significantly increased NRR rate, observed exclusively for ID testing performed at SDT sites, indicates a potential for contamination that may limit the number of samples that can optimally be processed using ID testing. The performance data for ID testing in particular should serve as a useful benchmark for evaluating candidate NAT systems that are fully automated.

No abstract